SCHEDULE 1Amendment of Titles 1 to 15

PART 1Amendment of Title 1: General issues

Chapter 1 of Title 1I11

In Article 1(1), omit “on the internal market”.

I22

1

Article 2 is amended as follows.

2

In paragraph 1(a), for “Council Directive 96/29/Euratom” to the end of the point substitute “ retained EU law that transposed Council Directive 2013/59/Euratom M1 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation M2; ”.

3

In paragraph 2, for “Directive 2006/12/EC” substitute “ Article 3(1) of Directive 2008/98/ECM3 ”.

4

After paragraph 2, insert—

F12A

For the purposes of this Regulation, “Directive 2008/98/EC” means that Directive as last amended by Directive (EU) 2018/851, and read in accordance with paragraphs 2B and 2C.

2B

Article 5 is to be read as if—

a

in paragraph 1, “Member States shall take appropriate measures to ensure that” were omitted;

b

after paragraph 1 there were inserted—

1A

Any decision as to whether a substance or object is a by-product must be made—

a

in accordance with any regulations setting out detailed criteria on the application of the conditions in paragraph 1 to specific substances or objects; and

b

having regard to any guidance published by the appropriate authority or the appropriate agency for the purposes of this Article.

c

paragraphs 2 and 3 were omitted.

2C

Article 6 is to be read as if—

a

in paragraph 1, “Member States shall take appropriate measures to ensure that” were omitted;

b

after paragraph 1 there were inserted—

1A

Any decision as to whether a substance or object has ceased to be waste must be made—

a

in accordance with any regulations or retained direct EU legislation setting out detailed criteria on the application of the conditions in paragraph 1 to specific types of waste; and

b

having regard to any guidance published by the appropriate authority or the appropriate agency for the purposes of this Article.

c

in paragraph 2—

i

the first subparagraph were omitted;

ii

in the second subparagraph, for “Those detailed criteria” there were substituted “Any detailed criteria set out in guidance as referred to in paragraph 1A”;

iii

the third and fourth subparagraphs were omitted;

d

paragraph 3 were omitted;

e

in paragraph 4—

i

in the first subparagraph—

aa

in the first sentence, for the words from the beginning to “Member State”, there were substituted “Where criteria have not been set out as referred to in paragraph 1A(a), the appropriate agency”;

bb

the second sentence were omitted;

ii

in the second subparagraph—

aa

for “Member States” there were substituted “The appropriate agency”;

bb

“by competent authorities” were omitted.

2D

In paragraphs 2B and 2C, “appropriate agency” means—

a

the Environment Agency, in relation to England;

b

the Natural Resources Body for Wales, in relation to Wales;

c

the Scottish Environment Protection Agency, in relation to Scotland.

5

In paragraph 3, for “Member States” substitute “ The Secretary of State ”.

6

Omit paragraph 4.

7

In paragraph 5—

a

for point (a) substitute—

a

in medicinal products for human or veterinary use within the scope of the Veterinary Medicines Regulations 2013 M4, or the Human Medicines Regulations 2012 M5;

b

for point (b)(i) substitute—

i

as a food additive in foodstuffs as defined by Article 3(2)(a) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives;

c

for point (b)(ii) substitute—

ii

as a flavouring in foodstuffs within the scope of Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods or Commission Implementing Regulation (EU) No 872/2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council;

d

for point (b)(iv) substitute—

iv

in animal nutrition within the scope of Article 2(1) of Regulation (EC) No 767/2009.

8

In paragraph 6—

a

for point (a) substitute—

a

medicinal products for human or veterinary use within the scope of the Veterinary Medicines Regulations 2013, or the Human Medicines Regulations 2012;

b

for point (b) substitute—

b

cosmetic products as defined in Regulation (EC) No 1223/2009 on cosmetic products;

c

for point (c) substitute—

c

medical devices which are invasive or used in direct physical contact with the human body in so far as legislation relating to the classification and labelling of dangerous substances and mixtures applies to them which ensures the same level of information provision and protection as Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures;

d

for point (d)(i) and (ii) substitute—

i

as a food additive in foodstuffs as defined by Article 3(2)(a) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives;

ii

as a flavouring in foodstuffs within the scope of Regulation (EC) No 1334/2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods or Commission Implementing Regulation (EU) No 872/2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council;

e

for point (d)(iv) substitute—

iv

in animal nutrition within the scope of Article 2(1) of Regulation (EC) No 767/2009.

9

In paragraph 7(c)—

a

for “from the Community” substitute “ from F2Great Britain ”;

b

for “into the Community” substitute “ into F3Great Britain ”.

10

In paragraph 7(d), for “F4the Community” substitute “ F5Great Britain ”.

Chapter 2 of Title 1I33

In Chapter 2 of Title 1, before Article 3 insert—

Article 2AThe Agency

1

The functions and powers of the Agency under the REACH legislation are to be functions and powers of the HSE.

Accordingly, any reference to the Agency in the REACH legislation must be read as meaning the HSE.

2

The general incidental powers of the HSE are to be exercisable for the purpose of carrying out the functions of the Agency under the REACH legislation.

But that does not limit the powers which the HSE has under the REACH legislation.

3

The non-REACH functions of the HSE are not limited by the functions of the Agency under the REACH legislation.

Accordingly, the HSE is not prevented from carrying out non-REACH functions in relation to a matter just because any of the functions of the Agency under the REACH legislation is also exercisable, or has been exercised, in relation to that matter.

4

The power of the Secretary of State under section 12(2)(a) of HASWA 1974 to give directions (as read with section 12(4) of HASWA 1974) is to be exercisable with respect to the functions of the Agency under the REACH legislation.

The Secretary of State may not give any such directions with regard to the enforcement of the REACH legislation in any particular case.

The Secretary of State must consider any request made by any of the other appropriate authorities for the Secretary of State to give a direction by virtue of this paragraph.

The function of giving directions by virtue of this section is subject to the consent requirement in Article 4A (whether or not there has been a request under the previous subparagraph).

5

In this Article—“general incidental powers” means the powers which the HSE has under—

a

section 13 of HASWA 1974, and

b

Schedule 2 to HASWA 1974;

“HASWA 1974” means the Health and Safety at Work etc. Act 1974 M6;“HSE” means the Health and Safety Executive;“non-REACH function” means any function which arises otherwise than under the REACH legislation;“REACH legislation” means—

a

this Regulation,

b

any instrument made under this Regulation, and

c

any retained direct EU legislation that was originally made under EU REACH.

Article 2BAdvice from Environment Agency or other environmental regulators to Agency

1

The Agency must comply with paragraph 2 when exercising—

a

its functions under—

i

Article 7(5),

ii

Article 9(4), (7) and (8),

iii

Article 21,

iv

Articles 40(1) and (3), 41(1), (3) and (5), 42(1), 43, 44, 45, 46(1) and (3), 48, 49, 51 and 52,

v

Articles 58(3) and (4) and 59(1), (2), (3), (6) and (7),

vi

Article 64(1), (3), (4), (5) and (6),

vii

Articles 69, 70 and 71, and

b

any of its other functions under this Regulation,

if, and to the extent that, the exercise of the function involves consideration of any relevant environmental issues.

2

The Agency must—

a

obtain the advice of the Environment Agency before exercising the function concerned, and

b

use the advice obtained when exercising the function concerned.

3

Whenever the advice of the Environment Agency is sought by the Agency under this Article, the Environment Agency must collaborate with the other environmental regulators when formulating the advice.

4

If, as part of a collaboration under paragraph 3, one of the other environmental regulators gives advice to the Environment Agency, the Environment Agency must pass that advice on to the Agency if that other environmental regulator requires it to do so.

5

In this Article—“other environmental regulator” means—

a

in relation to Wales, the Natural Resources Body for Wales;

b

in relation to Scotland, the Scottish Environment Protection Agency;

F6c

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“relevant environmental issue” means—

a

exposure of the environment to chemicals;

b

exposure of humans to chemicals in the environment;

c

assessment of the potential effect of chemicals on the environment;

d

measures aimed at controlling the release of chemicals into the environment.

I44

1

Article 3 is amended as follows.

2

Before paragraph 1 insert—

A1

EU REACH: means Regulation (EC) No 1907/2006 of the European Parliament and of the Council M7 as it has effect in EU law;

A2

appropriate authority: means—

a

the Secretary of State, in relation to England;

b

the Scottish Ministers, in relation to Scotland;

c

the Welsh Ministers, in relation to Wales;

F7d

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F8. . .

3

In paragraph 4, for “F9the Community” substitute “F10Great Britain”.

4

In paragraph 9, for “F11the Community”, in both places it occurs, substitute “F12Great Britain”.

5

In paragraph 10, for “F13the customs territory of the Community” substitute “F14Great Britain”.

F155A

After paragraph 10, insert—

10A

protected NI import: has the meaning given by Article 139A(2);

10B

qualifying Northern Ireland good: has the meaning given to it from time to time in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018.

6

In paragraphs 11, 13 and 14, for “F16the Community” substitute “F17Great Britain”.

7

For paragraph 18 substitute—

18

Agency: see Article 2A;

18A

ECHA: means the European Chemicals Agency established under EU REACH;

8

Omit paragraph 19.

9

In paragraph 20, in points (b) and (c)—

a

for “Community” substitute “European Community”;

b

for “the entry into force of this Regulation” substitute “1 June 2007”.

10

In paragraph 21, for “has been” substitute “was”.

11

In paragraph 36, at the end insert—

and, in its application for the purposes of this paragraph, the Annex to that Recommendation has effect with the following modifications—

a

in Article 2(1)—

i

the reference to EUR 50 million has effect as a reference to £43.650 million;

ii

the reference to EUR 43 million has effect as a reference to £37.539 million;

b

in Article 2(2) the reference to EUR 10 million has effect as a reference to £8.730 million;

c

in Article 2(3) the reference to EUR 2 million has effect as a reference to £1.746 million;

d

in Article 3(2)—

i

in point (a), the reference to EUR 1,250,000 has effect as a reference to £1,091,250;

ii

in point (d), the reference to EUR 10 million has effect as a reference to £8.730 million.

I55

After Article 4 insert—

Article 4AThe consent requirement

1

Where any provision of this Regulation states that a function is subject to the consent requirement in this Article, the function may be exercised in a particular instance only if the person exercising it has obtained the consent or consents (if any) required by paragraphs 2 to 4.

2

The consent of the Scottish Ministers is required if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 54 of the Scotland Act 1998 M8), whether or not the exercise of the function also relates to a part of F18Great Britain other than Scotland.

3

The consent of the Welsh Ministers is required if, or to the extent that, the exercise of the function is within devolved competence (within the meaning of section 58A(7) and (8) of the Government of Wales Act 2006 M9) whether or not the exercise of the function also relates to a part of F18Great Britain other than Wales.

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F195

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F196

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F197

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F198

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